(29 days)
The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.
The provided document describes the CLUNGENE HCG Pregnancy Rapid Test, a qualitative in vitro diagnostic device for early detection of pregnancy. The acceptance criteria and study details are primarily focused on the analytical performance and comparison with a predicate device, as this is a 510(k) submission for a Class II device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance characteristic in a pass/fail format. However, based on the presented data, the implicit acceptance criterion for most analytical tests is 100% agreement/expected result at the defined concentrations. For the sensitivity, the acceptance criterion is implied to be 25 mIU/mL, as this is the claimed analytical detection limit, and the results show 100% positivity at 25 mIU/mL and above. For the method comparison and lay person studies, 100% concordance with the reference method (predicate device or professional testing) suggests an implicit acceptance criterion of 100% agreement.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: 100% positive at 25 mIU/mL hCG and above, and 100% negative at 12.5 mIU/mL hCG and below. | Strip Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. |
| Cassette Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. | |
| Midstream Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. | |
| Hook Effect: No hook effect observed at high hCG concentrations. | Tested up to 2,000,000 mIU/mL hCG. All tested concentrations gave a positive result, demonstrating no hook effect from 62500 to 2,000,000 mIU/mL. |
| Specificity/Cross-reactivity: No interference from high concentrations of related hormones (LH, FSH, TSH, hCG ß-core fragment). | No interference observed at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH, and 2,000,000 pmol/L hCG ß-core fragment for both negative (10 mIU/mL) and positive (25 mIU/mL) urine samples. |
| Interfering Substances: No interference from common endogenous and exogenous substances (various drugs, metabolites, etc.). | No interferences observed from a long list of exogenous compounds (e.g., Acetaminophen, Caffeine, Ethanol, Aspirin, etc.) at specified concentrations for both negative (10 mIU/mL) and positive (25 mIU/mL) hCG urine samples. No interference from changes in pH (4-9) or specific gravity (1.000-1.035) for 10 mIU/mL and 25 mIU/mL hCG samples. |
| Method Comparison (Conformity Rate): 100% positive and negative conformity with the predicate device. | Strip Format: 100% positive conformity (63/63), 100% negative conformity (57/57). |
| Cassette Format: 100% positive conformity (63/63), 100% negative conformity (57/57). | |
| Midstream Format: 100% positive conformity (63/63), 100% negative conformity (57/57). | |
| Lay Person Study (Conformity Rate): 100% positive and negative conformity with professional results. | Strip Format: 100% positive conformity (43/43), 100% negative conformity (57/57). |
| Cassette Format: 100% positive conformity (53/53), 100% negative conformity (47/47). | |
| Midstream Format: 100% positive conformity (50/50), 100% negative conformity (50/50). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Analytical Performance (Precision/Reproducibility/Sensitivity, Hook Effect, Specificity, Interfering Substances): Urine samples were spiked with hCG standards and various interfering substances. The origin of the initial negative urine is not specified but is typically a controlled laboratory setting. The study design for these tests appears to be prospective laboratory testing.
- Precision/Reproducibility/Sensitivity: 90 replicates per hCG concentration (3 lots * 30 replicates each) were tested for each of the three formats. Negative urine was spiked with hCG standard (Traceable to the 5th WHO).
- Hook Effect: Negative urine samples were spiked with varying hCG concentrations.
- Specificity and Cross-reactivity: Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones and hCG ß-core fragment.
- Interfering Substance: Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substances.
- Method Comparison Study:
- Sample Size: 120 urine samples from women presenting to test for pregnancy. Approximately half were suspected to be pregnant and in early stages (less than 5 weeks).
- Data Provenance: Not explicitly stated but implies prospective collection from "POC sites" (Point-of-Care). Country of origin is not mentioned.
- Lay Person Study:
- Sample Size: 300 women.
- Data Provenance: Not explicitly stated, but participants were recruited from "three sites" for self-testing. Implies prospective collection. Country of origin not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Analytical Performance: The ground truth for analytical performance (e.g., hCG concentrations) was established by spiking known concentrations of hCG standard traceable to the 5th WHO, and preparing samples with known concentrations of interfering substances. This implies a laboratory setting with qualified personnel to perform and verify the spiking, but "experts" in the sense of clinical interpretation are not involved here.
- Method Comparison Study: The ground truth was established by testing all samples with the predicate device AND by "three different health professionals for each format at the 3 POC sites for a total of 12 POC operators." The qualifications of these "health professionals" or "POC operators" are not specified beyond being "health professionals."
- Lay Person Study: The ground truth was established by "professional testing" of the urine samples provided by the lay persons. The qualifications of these "professionals" are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Analytical Performance: Not applicable for spiked samples with known concentrations. The results are quantitative (e.g., 30 positives out of 30, 0 negatives out of 30).
- Method Comparison Study: The study involved professional testing of each sample by "three different health professionals" and comparison to the predicate device. It's not explicitly stated if there was an adjudication process if these three professionals disagreed among themselves, or if the predicate device result was considered the definitive ground truth for comparison. The tables indicate a direct comparison between the candidate device and the predicate device.
- Lay Person Study: Each lay person's result was compared to "professional testing." It's not explicitly stated if there was an adjudication for professional testing if multiple professionals were involved or if it was a single professional's reading.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a rapid diagnostic test (HCG Pregnancy Rapid Test), not an AI-powered image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The "multi-reader" aspect in the method comparison and lay person studies refers to different operators/professionals performing the assay, not interpreting complex images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a lateral flow immunoassay that produces a visual result, interpreted by a human user (either a professional or a lay person). There is no "algorithm only" component to evaluate in isolation. Its performance is its standalone performance when correctly used and interpreted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance: Ground truth was based on known, spiked concentrations of hCG (traceable to WHO International Standard) and other substances in urine. This is a highly controlled laboratory ground truth.
- Method Comparison Study: Ground truth was established by comparison to a legally marketed predicate device and readings by "health professionals." The predicate device results served as the reference standard.
- Lay Person Study: Ground truth was established by "professional testing" of the urine samples from the lay persons.
8. The sample size for the training set
- This document describes performance characteristics for a rapid diagnostic test. There is no mention of a "training set" as this is not an AI/machine learning model that requires training. The studies conducted are for analytical validation and clinical performance evaluation.
9. How the ground truth for the training set was established
- As there is no training set mentioned or implied for this type of device, this question is not applicable.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.